Louisiana Price Transparency Measures Go into Effect …With An Interesting Twist
According to LexisNexis State Net, during 2017, about half of the states and Congress collectively introduced almost 90 measures intended to address soaring prescription drug prices. Most would either cap drug prices or force drug makers to be more transparent with how they devise pricing for at least some medications. A handful of states, including Maryland (HB 631), Louisiana (SB 59) and Nevada (HB 539), have adopted such measures this year, and New York adopted a law in April as part of the budget that imposes greater scrutiny on drug makers over their pricing. There is also word that the Trump administration is...
Source: Policy and Medicine - September 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Celgene Settles Whistleblower Suit for $280 Million
Late July 2017, Celgene Corp., a manufacturer of pharmaceuticals, agreed to pay $280 million to settle fraud allegations related to the promotion of two cancer treatment drugs for uses not approved by the United States Food and Drug Administration (FDA). The settlement resolves allegations brought in a “whistleblower” lawsuit that Celgene promoted two cancer drugs – Thalomid and Revlimid – for uses that were not approved by the FDA and not covered by federal health care programs. The allegations included the use of false and misleading statements about the drugs, and paying kickbacks to physicians to induce them t...
Source: Policy and Medicine - September 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New Report Outlines Steps for Greater Transparency
In July 2017, The Network for Excellence in Health Innovation (NEHI) released a new report that outlines steps for greater transparency in health care. The report states that helping consumers make well-informed decisions can lead to higher quality of care, greater patient satisfaction and better use of the nation’s health care resources. NEHI found that most consumers make medical decisions without proper support, after interviewing health care industry experts, holding a discussion with thought leaders, and reviewing existing research. Choosing a doctor, hospital, health insurance plan, or a course of med...
Source: Policy and Medicine - September 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

This Isn ’t Walmart: The Supreme Court Narrows Forum-Shopping Options
This article outlines the background, the case decision, and the decision’s ramifications to companies. As the arguments about why pharmaceutical prices are rising so quickly grow more contentious, so too has the debate about tort reform and products liability. Recently, during one of last days of its most recent term, the United States Supreme Court (“SCOTUS”) issued a decision that will make it harder for plaintiffs to sue corporations in state courts for damages caused by manufacturers’ products. The nearly unanimous decision in Bristol-Myers Squibb Co. v....
Source: Policy and Medicine - September 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New Jersey Governor Christie Introduces Regulation to Cap Physician-Pharma Relationships
In the last days of his administration, New Jersey Governor Chris Christie has introduced a regulation to cap the amount physicians can earn from drug companies – an already rule-laden area – to $10,000 per year. The Regulation In addition to the $10,000 per year cap on any earnings from pharma to physicians, prescription writers are prohibited from accepting certain gifts, such as entertainment and lavish meals (an exception is carved out for four meals a year under $15). The $10,000 cap excludes compensation for speaking at continuing education events. The new regulations detail the different kinds of services –...
Source: Policy and Medicine - September 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Fine Art of Policy Management
Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance from the Justice Department and OIG-HHS about effective compliance programs does elaborate on what a strong policy management program should do. In this article, we examine five basic abilities that all policy management programs should have—things that your program must be able to do, regardless of your organization’s specific structure and processes, if you want an effective program that can endure in today’s highly regulated environ...
Source: Policy and Medicine - September 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

DOJ Announces Another FCA Settlement - Sightpath Medical and TLC Vision Corporation
In late August 2017, the United States Department of Justice (DOJ) announced a $12 million settlement with Sightpath Medical and TLC Vision Corporation, as well as the former CEO of both entities, James Tiffany. The suit was brought by Kipp Fesenmaier, former vice president of the company, in 2013 for allegedly violating the False Claims Act and the Anti-Kickback Statute. Fesenmaier claimed that Sightpath knowingly took advantage of Medicare by using extravagant trips and social events to entice doctors to use its products and services, which were then billed to government healthcare programs. The complaint alleges ...
Source: Policy and Medicine - September 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Independent Review Organizations ( “IRO”) and Conflicts of Interest - Much Ado About Nothing or a Serious Problem
This article examines the various view points and what it means for the life science compliance professional. Although the concept of the Independent Review Organization or IRO has been around for many years, with the advent of Sarbanes-Oxley in 2002, the IRO came to the forefront in life sciences. During the settlement of compliance and regulatory claims with life-science companies, the government typically now requires companies to retain IROs to assist in the investigation, review, negotiations, and settlement process. Requiring an IRO has become so ingrained in t...
Source: Policy and Medicine - September 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Chicago Proposes Drug Pricing Transparency Ordinance
Chicago Alderman Edward M. Burke recently held a hearing on the proposed city ordinance, “Chicago Drug Pricing Transparency Ordinance.” The ordinance would mandate that pharmaceutical manufacturers whose drugs are sold in Chicago must disclose any rise in prices ninety days in advance if those increases fall within one of the pre-selected categories. The ordinance proposes establishing a Prescription Drug Price Review Board, which shall be responsible for: (1) reviewing trends in the list price of medications dispensed or prescribed through its services – either directly or through public and private partnerships; (...
Source: Policy and Medicine - September 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Independent Review Organizations ( “IRO”) and Conflicts of Interest - Much Ado About Nothing or a Serious Problem
This article examines the various view points and what it means for the life science compliance professional. Although the concept of the Independent Review Organization or IRO has been around for many years, with the advent of Sarbanes-Oxley in 2002, the IRO came to the forefront in life sciences. During the settlement of compliance and regulatory claims with life-science companies, the government typically now requires companies to retain IROs to assist in the investigation, review, negotiations, and settlement process. Requiring an IRO has become so ingrained in t...
Source: Policy and Medicine - September 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Chicago Proposes Drug Pricing Transparency Ordinance
Chicago Alderman Edward M. Burke recently held a hearing on the proposed city ordinance, “Chicago Drug Pricing Transparency Ordinance.” The ordinance would mandate that pharmaceutical manufacturers whose drugs are sold in Chicago must disclose any rise in prices ninety days in advance if those increases fall within one of the pre-selected categories. The ordinance proposes establishing a Prescription Drug Price Review Board, which shall be responsible for: (1) reviewing trends in the list price of medications dispensed or prescribed through its services – either directly or through public and private partnerships; (...
Source: Policy and Medicine - September 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA
On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court d...
Source: Policy and Medicine - August 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The EpiPen Whistleblower Saga Comes to a Close
Last week, Mylan Inc. and Mylan Specialty L.P. (hereinafter “Mylan”) reached an agreement with the United States Department of Justice (“DOJ”) to pay $465 million to resolve claims that they violated the False Claims Act (“FCA”). Mylan knowingly misclassified EpiPen as a generic drug, attempting to avoid paying rebates that were owed to Medicaid. The settlement resolves the government’s allegations that Mylan, by erroneously reporting EpiPen as a generic drug to Medicaid despite the absence of any therapeutically equivalent drugs, was able to demand massive price increases in the private market while avoidin...
Source: Policy and Medicine - August 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA
On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court d...
Source: Policy and Medicine - August 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The EpiPen Whistleblower Saga Comes to a Close
Last week, Mylan Inc. and Mylan Specialty L.P. (hereinafter “Mylan”) reached an agreement with the United States Department of Justice (“DOJ”) to pay $465 million to resolve claims that they violated the False Claims Act (“FCA”). Mylan knowingly misclassified EpiPen as a generic drug, attempting to avoid paying rebates that were owed to Medicaid. The settlement resolves the government’s allegations that Mylan, by erroneously reporting EpiPen as a generic drug to Medicaid despite the absence of any therapeutically equivalent drugs, was able to demand massive price increases in the private market while avoidin...
Source: Policy and Medicine - August 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs